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New inhaled drug shows promise for cystic fibrosis in early trial

NCT ID NCT06478706

Disease control Sponsor: Enterprise Therapeutics Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an inhaled drug called ETD001 in 57 adults with cystic fibrosis. The trial had two parts: one to check safety over 7 days, and another to see if the drug improves lung function over 28 days. Participants took the drug or a placebo twice daily. The goal is to find a new treatment that helps people with CF breathe easier.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ETD001 (inhaled drug)
What this could lead to
If successful, this could lead to a new inhaled treatment that improves lung function in people with cystic fibrosis.
What could go wrong
This is an early Phase 2 trial with only 57 participants, so results may not apply to everyone. The drug may not improve lung function or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

57 people

The number who actually took part.

Started

Jun 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male \& female ≥ 18 years of age, who fit one of the following criteria: Women of childbearing potential using permitted contraception a minimum of 28 days before dosing until completion of the final follow up visit; Women of non-childbearing potential; Men using contraception from the time of the first dose, until completion of the final follow up visit; * Confirmed diagnosis of CF * FEV1 ≥ 40% and ≤ 90% of predicted normal for age, gender, and height * Able to reproducibly perform spirometry manoeuvres * Clinically stable CF lung disease * Routine CF therapy has not changed within 28 days prior to screening. * Provided written informed consent. * Body mass index (BMI) \> 16 and \< 30 kg/m2 Exclusion Criteria: * Abnormal liver function * Abnormal renal function * History of solid organ transplant * Chest x-ray within the past 12 months with abnormalities suggesting unstable pulmonary disease other than CF * Received CFTR modulator therapy in the 60 days before screening * Changes in bronchodilator, corticosteroid or other anti-inflammatory medications 14 days before screening * Unable to withhold use of long-acting bronchodilators 24 hours or short-acting bronchodilators 6 hours before spirometry assessments * Unable to withhold use of anti-cholinergics within 24 hours of spirometry * Started dornase alfa, hypertonic saline, or other airway clearing therapy less than 28 days before screening * Using inhaled antibiotics for less than 2 complete cycles and unable to complete the entire study during the off or on cycle. * Changes in inhaled or oral antibiotic use within 14 days of screening * Taking oral corticosteroids in excess of 10 mg/day or 20 mg every other day within 14 days of screening * Use of diuretics, or renin-angiotensin aldosterone system antihypertensive drugs , drospirenone, or trimethoprim in the 28 days before screening * Presence of co-morbidities and medical history in the opinion of the investigator, may pose additional risk by participating in the study, or may confound the results of the study

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

Contacts and locations

Locations

  • All Wales Adult CF Centre

    Cardiff, CF64 2XX, United Kingdom

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126, Italy

  • Azienda Ospedaliera Universitaria Meyer

    Florence, 50139, Italy

  • Belfast Health and Social Care Trust

    Belfast, BT9 7AB, United Kingdom

  • CF-Studienzentrum Universitätsklinikum Köln

    Cologne, 50924, Germany

  • CHU de Montpellier

    Montpellier, 34295, France

  • Charité Universtaetsmedizin

    Berlin, 13353, Germany

  • Fondazione IRCCS Ca' Granda- Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Hospices Civils de Lyon

    Lyon, 69495, France

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpitaux de Toulouse

    Toulouse, 31059, France

  • IKF Pneumologie

    Frankfurt, 60596, Germany

  • IRCCS Istituto Giannina Gaslini

    Genova, 16147, Italy

  • LMU Kinikum

    Munich, 80336, Germany

  • Ospedale Pediatrico Bambino Gesù

    Roma, 00165, Italy

  • Queen Elizabeth University Hospital West of Scotland CF Service

    Glasgow, G51 4TR, United Kingdom

  • Royal Brompton Hospital

    London, SW3 6LL, United Kingdom

  • Royal Papworth Hospital

    Cambridge, CB2 0AY, United Kingdom

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Westdeutsches Lungenzentrum am Universitätsklinikum

    Essen, 45239, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.